Merck & Co. Receives the US FDA’s Approval for Welireg (belzutifan) to Treat Advanced Renal Cell Carcinoma (RCC)
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- Merck received the US FDA’s approval based on the results from the P-III (LITESPARK-005) clinical trial evaluating the safety & efficacy of Welireg (120mg, QD) vs everolimus (10mg, QD) in patients (n=746), in the ratio 1:1, with advanced RCC that progressed following PD-1 or PD-L1 checkpoint inhibitor & VEGF receptor-targeted therapies
- As per the results, the trial depicted a PFS of 5.6mos. vs 5.6mos., ORR of 22% vs 4%, CR of 3% vs not achieved with everolimus & PR of 19% vs 4%
- Moreover, out of the 82 patients achieving confirmed responses on receiving Welireg (HIF-2α inhibitor), 30% showed a DoR of ≥12mos. whereas disease progression was reduced by 25% & mDoE was 7.6mos. in patients receiving Welireg
Ref: Merck | Image: Merck
Related News:- Merck Reports the US FDA’s Acceptance of sNDA and Granted Priority Review of Welireg (belzutifan) for Advanced Renal Cell Carcinoma
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
